Brussels, 10 June 2026 - EuropaBio, the European Association for Bioindustries, has submitted its response to the European Commission’s call for evidence on the EU Biotech Act II, calling for a bold, coordinated and cross-sectoral legislative framework to fully realise Europe’s biomanufacturing potential.

Building on the progress of Biotech Act I, EuropaBio highlights the need for a second phase that recognises Europe’s advances in key areas of biotechnology and extends these towards the full delivery of biomanufacturing. As a central pillar of Europe’s economic strength, supply chain resilience and sustainable future, biomanufacturing requires a legislative framework that applies across all sectors, including health and food, and reflects the unique challenges faced across these domains.

A core priority is the completion of a coherent and robust EU regulatory ecosystem. EuropaBio calls for Biotech Act II to finalise a fit-for-purpose regulatory environment for microorganisms, building on ongoing legislative improvements, and to strengthen EFSA pathways and operations. Together, these measures can establish a comprehensive foundation for biomanufacturing in the EU. The Act should also ensure stronger coordination between regulatory agencies, creating a tangible operational framework that reduces fragmentation within and across sectors.

Ensuring a predictable and investable environment for biotechnology is equally critical. EuropaBio underlines the importance of strengthening financing, funding and investability across the full innovation pipeline, from research to scale-up and market deployment. This includes expanding access to both public and private finance, while implementing measures that simplify processes, increase predictability, open markets and support rapid innovation. Such actions are key to accelerating investment and scaling biomanufacturing in Europe.

The submission also highlights the need to unlock access to renewable and circular carbon feedstocks, including biomass and industrial side streams, as a cornerstone of a competitive and sustainable bioeconomy. Enabling access to these resources, while maintaining high safety standards, will support all industrial sectors in meeting sustainability targets and transitioning towards a circular economy. In this context, clear frameworks for carbon accounting and traceability are essential to measure progress towards Europe’s climate objectives.

To strengthen Europe’s global competitiveness and resilience, EuropaBio calls for the creation of lead markets for biomanufactured products through targeted policy and fiscal tools focused on strategic value chains. In parallel, the EU must simplify and harmonise export mechanisms across Member States to strengthen its role as a trusted global producer. This will be critical to ensuring economic security and resilience within an increasingly complex global supply chain landscape.

Finally, maintaining Europe’s leadership in bioprocessing and industrial scale-up remains essential. EuropaBio highlights the importance of EU-wide initiatives such as biomanufacturing corridors and connected bioprocess hubs to maximise performance across Member States, while supporting economic growth, skills development, job creation and resilient supply chains.

Dr. Claire Skentelbery, Director General of EuropaBio, said: “The call for evidence for the Biotech Act II could not be more timely or important. With today's global pressure on economies and supply chains, plus regional acceleration into biomanufacturing, the EU cannot be caught napping. This next vital phase in the Biotech Act must complete a modern biomanufacturing ecosystem and we are here to help achieve this.”

Read and download the full press release and consultation response